2023-09-13 07:55:31
by Vera Martinella
The therapy was given the green light by Aifa: a 36% reduction in the risk of death was also reported. Indicated in HER2 positive breast cancer (even with brain metastases) in patients who have already had a first line of treatment
The tumor, which is already metastatic, remains stagnant for an average of 28 months before starting to progress again. 28 months with a new drug, now also available in Italy, compared to six with the therapies used so far. But for many patients it goes well beyond two and a half years, during which the therapy is continued, which is well tolerated and has a toxicity that does not generally prevent carrying out normal daily activities. And there’s more: they are patients who have already received many other treatments previously and who benefit even in the presence of brain metastases.
52 thousand metastatic patients in Italy
There are many important reasons that led the Italian Medicines Agency (Aifa) to approve trastuzumab deruxtecan for those with unresectable or metastatic HER2-positive breast cancer who have received one or more previous regimens based on other anti-HER2 treatments. In 2022, in Italy, approximately 55,700 new cases of breast cancer have been estimated, the most frequent neoplasm in the entire population – underlines Saverio Cinieri, president of the Italian Association of Medical Oncology (Aiom) -. One in 8 women will get sick during their lifetime and it is important to remember that men can also develop it, although it is a very rare event. Thanks to the successes in early diagnosis and new therapies, today 87% of patients are alive 5 years after diagnosis, but above all against the more aggressive forms and those in the metastatic stage we need innovative strategies to extend the lives of patients or to increase the number of healings. And with the arrival of trastuzumab deruxtecan the standard of care in second line treatment in HER2-positive metastatic breast cancer changes. There are approximately 52 thousand people with metastatic breast cancer in our country, a number that is constantly increasing – adds Cinieri -: 20% have an overexpression of the HER2 protein and can benefit from this new treatment. The disease can recur in the metastatic form even many years after surgery and the end of postoperative therapies. Furthermore, there is a percentage of patients, equal to 7%, in which the tumor is already metastatic at the time of diagnosis.
Lo studio DESTINY-Breast03
Targeted therapies, in particular anti-HER2 drugs, have changed the history of metastatic breast cancer, resulting in many cases in a long life expectancy, much higher than in the past. Aifa’s green light for trastuzumab deruxtecan is based on the results achieved by the DESTINY-Breast03 trial, which enrolled 524 patients and demonstrated that the new molecule is more effective than a first-generation conjugated antibody (trastuzumab emtansine or T-DM1), resulting in a notable improvement in disease control. The 524 participants had HER2-positive metastatic breast cancer previously treated with trastuzumab and chemotherapy – explains Giuseppe Curigliano, Professor of Medical Oncology at the University of Milan and director of the Development of New Drugs for Innovative Therapies Division at the European Institute of Oncology in Milan – . Trastuzumab deruxtecan demonstrated an improvement in median progression-free survival of 22 months compared to T-DM1 (28.8 months vs. 6.8 months). This is an unprecedented result in the history of the pathology. The 36% reduction in the risk of death was also significant, furthermore 77.4% of patients were alive at two years compared to 69.9% with T-DM1.
Results never seen before
The new drug is a drug-conjugated monoclonal antibody, which means it combines a monoclonal antibody designed to bind specifically to the HER2 protein, trastuzumab, with a cytotoxic agent, deruxtecan, to treat specific types of neoplasia – continues Curigliano -. Trastuzumab deruxtecan is administered intravenously every three weeks and is highly selective for tumor cells, minimizing damage to surrounding healthy cells and increasing the effectiveness of the treatment. The superiority also emerged in terms of quality of life, thanks to better control of the disease and symptoms. We recently published quality of life data from patients included in the DESTINY-Breast03 study. In the study, despite the longer duration of treatment, the patients’ quality of life did not worsen. Indeed, the period in which patients do not need to be hospitalized is significantly extended, so much so that the first visit to hospital occurs on average after 216 days from the start of treatment with the new drug compared to 50 days with T-DM1 . This new treatment responds to a great need: to have a highly effective therapy, to be administered over a long period – says Lucia Del Mastro, Clinical Director of Medical Oncology at the IRCCS San Martino Polyclinic Hospital and Professor at the University of Genoa —. And with results never seen before.
Get treatment in the Breast Units
In all phases of the disease, for women with breast cancer, we refer to the Breast Units, specialized centers, where various experts discuss and improve patient survival. They are essential to guarantee patients a multidisciplinary approach and a better life expectancy – underlines Del Mastro -. Access to Breast Units in the metastatic stage is unfortunately less frequent than what happens for those with breast cancer in the early stages, but it has been demonstrated that the therapeutic results also depend on the level of experience gained by the centers in which the treatments are carried out. We therefore need the collaboration of patient associations to raise awareness among all women of the importance of being treated in Breast Units. A woman with metastatic breast cancer must undertake a complex path not only from a therapeutic point of view, but also psychological and emotional – remember Anna Maria Mancuso, president of Salute Donna Onlus —. It is therefore essential that specific diagnostic and therapeutic care pathways are adopted for patients with advanced cancer, who are increasingly numerous also thanks to the great strides made by scientific research. Metastatic breast cancer today is becoming an increasingly treatable pathology – concludes Rosanna D’Antona, president of Europa Donna Italia —. The formal institution of the dedicated National Day, which is celebrated every year on 13 October and strongly supported by patient associations, does not represent a point of arrival but of departure. In addition to the specific paths within the Breast Units, where a multidisciplinary team must be present and access to tests for frequent diagnostic checks must be facilitated, it is important to guarantee rapid access to innovative drugs, information on clinical trials, the assistance of the psycho-oncologist and the assessment of civil disability in a short time.
September 13, 2023 (changed September 13, 2023 | 07:55)
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